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SNMMI Comments on FDA Data Integrity and Compliance with CGMP

July 21, 2016

The Society of Nuclear Medicine and Molecular Imaging (SNMMI)  provided comments on FDA’s draft Guidance Document on Data Integrity and Compliance with CGMP.

The U.S. Food and Drug Administration (FDA) released new draft guidance in April to help the pharmaceutical industry ensure data is consistent and accurate. The guidance includes 18 questions and answers on data integrity, as well as defined terms on data as they relate to current good manufacturing practice (cGMP) records, recommendations on when workflows on computer systems validation, and ensure electronic master production and control records (MPCR).

SNMMI addressed several concerns with the guidance, such as the need for FDA to delineate the difference between PET drug manufacturing and conventional drug manufacturing, allowing PET radiopharmaceutical firms to implement meaningful and effective strategies for data integrity, challenges with electronic audit systems requirements, and batch records.  

Read the full comment letter »